Biogen's Fampyra Conditional Approval Converted To Standard
Zacks Investment Research | May 24, 2017 09:16PM ET
Biogen Inc. (NASDAQ:BIIB) announced that the conditional marketing authorization for its drug Fampyra for improvement of walking in multiple sclerosis (MS) patients in the EU has been converted to a standard marketing approval.
As part of the conditional approval received in 2011, Biogen was required to provide additional data on the long-term safety and benefits of Fampyra, especially on the drug’s benefits beyond an improvement in walking speed.
The standard approval was based on positive results of the phase III ENHANCE study, which was conducted to evaluate the long-term safety and efficacy of Fampyra in patients with both relapsing and progressive forms of MS. The study confirmed the clinically meaningful benefits and safety of Fampyra over the long term.
Fampyra is available in the U.S. under the trade name Ampyra where it is marketed by Acorda Therapeutics, Inc. (NASDAQ:ACOR) . Biogen acquired ex-U.S. rights to Fampyra from Acorda in Jul 2009
Biogen has a strong position in the MS market with a wide range of products including Avonex, Tysabri, Tecfidera and Plegridy. Biogen has another MS product, Zinbryta, in its portfolio in partnership with AbbVie, Inc. (NYSE:ABBV) . However, increasing competition and a slowdown in the overall MS market is hurting sales of it MS drugs lately. Importantly, Roche’s Ocrevus (ocrelizumab) was approved for the treatment of relapsing MS (RMS) and primary progressive MS (PPMS) in Mar 2017, which will pose strong competition to Biogen’s MS drugs. However, on Wednesday, Reuters reported that a progressive multifocal leukoencephalopathy (PML) case has been disclosed in a MS patient in Germany who had recently switched to Ocrevus from Tysabri.
Shares of Biogen were up 2% on Wednesday. This year, Biogen’s shares have declined 10.6% so far while the Zacks classified Zacks Investment Research
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